Dragonfly device study for functional mitral valve leakage
Part of Heart & circulation clinical trials.
This trial tests a catheter-based procedure (putting a small device through blood vessels) to repair a leaking mitral valve caused by heart muscle problems. It aims to reduce symptoms and improve heart function and safety in people who are still having heart failure symptoms despite standard treatment.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are 18 or older.
- You have symptomatic functional mitral regurgitation (mitral valve leakage caused by heart muscle weakness) and it must be confirmed on an echocardiogram—without signs of “degenerative” valve damage.
- Your heart treatment has been stable for at least 30 days, and a heart ultrasound was done after that stabilization.
- Your symptoms are in the NYHA class II to IVa, and your heart pumping is moderately reduced (ejection fraction 20% to 50%).
- Your mitral valve anatomy is suitable for this edge-to-edge, catheter-based repair, and blood-vessel access for the procedure is feasible.
- You likely have evidence of worsening heart failure (for example, high BNP/NT-proBNP or a heart failure hospitalization in the past 12 months).
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
Similar studies
Other trials that look related to this one.
This trial tests a device called the Dragonfly system to fix a leaky mitral valve caused by heart muscle problems. It may help people with symptoms like shortness of breath or fatigue from this condition.
This trial tests a new device designed to fix a leaky mitral valve in people with heart failure. It may help you breathe easier and feel less tired if your valve leak is severe and medicines have not been enough.
This study tests a procedure to fix a leaky heart valve (mitral valve) in people with heart failure, with the goal of helping them tolerate and benefit from standard heart failure medicines. It asks whether adding this valve repair to optimized medicines is better than medicines alone.
This trial tests a procedure called transcatheter edge-to-edge repair (TEER) for people with a specific type of heart valve leak (functional mitral regurgitation) that is causing heart failure symptoms. The procedure is less invasive than open-heart surgery and aims to improve symptoms and quality of life.
This trial tests the safety and effectiveness of a heart procedure that repairs a leaking mitral valve through thin tubes, using the Dragonfly system. It’s for people who have significant mitral valve leak symptoms but are considered high risk for open-heart surgery.
This trial tests a new device (DragonFly M2) to fix a leaky mitral valve. It's for people with moderate to severe or severe chronic mitral regurgitation who may be able to have the procedure done through a vein in the leg.
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